This is a prospective, multi-center, open-label, single-arm feasibility trial to assess device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart failure patients who will receive the Cordella™ Sensor implant.
The objectives of this study are to establish that the Cordella™ Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant as well as to measure the accuracy of Cordella™ Sensor PA pressure measurements compared with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant. Safety measures will include the frequency and rates of adverse events, both overall and for each specific event, which will be collected throughout the study. Subjects will remain in this trial for 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
The Cordella™ Heart Failure System collects, records, and transmits physiologic data and communications from the patient at home to clinicians for assessment, patient communication, and patient-centered heart failure management. The system consists of the following components: 1. myCordella™ Patient Management Portal 2. myCordella™ Hub 3. myCordella™ Peripherals, including the Cordella™ Pulmonary Artery Sensor System (CorPASS)
Ziekenhuis Oost Limburg
Genk, Belgium
Galway University Hospital
Galway, Ireland
Safety Freedom form Adverse events
Freedom from adverse events associated with use of the Cordella™ HF System
Time frame: 30 days
Efficacy: Accuracy
Accuracy of Cordella™ Sensor PA pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard Right Heart Catheter
Time frame: 90 days
Frequency of Adverse Events
Frequency of adverse events throughout the study
Time frame: 30 days and 2 years
Device/system-related complications
Device/system-related complications
Time frame: 30 days and 2 years
Pressure sensor failure rate
Pressure sensor failure rate throughout the study
Time frame: 30 days and 2 years
Accuracy of Cordella™ sensor pressure measurements
Accuracy of Cordella™ Sensor PA pressure measurements compared with echo pulmonary artery pressure (PAP) measurements
Time frame: 2 years
Percentage of device success
Percentage of device success as documented by ability of the System to successfully transmit collected data to a secure database
Time frame: 90 days
Change in Pulmonary Artery (PA) pressure
Change in PA pressure pre- and post-implant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 90 days
Heart Failure (HF) Hospitalizations
Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits.
Time frame: 90 days
Quality of Life measured by Kansas City Cardiomyopathy Questionnaire
Quality of Life measured by KCCQ at 90 days and 2 years post implant procedure
Time frame: 90 days and 2 years
Quality of Life measured by EuroQOL EQ-5D-5L
Quality of Life measured by EuroQOL EQ-5D-5L at 90 days and 2 years post implant procedure
Time frame: 90 days and 2 years
Adherence to regular myCordella™ Peripherals measurements
Adherence to regular myCordella™ Peripherals measurements
Time frame: 90 days and 2 years